Cleared Traditional

K142567 - RETeval Visual Electrodiagnostic Device

K142567 is the FDA 510(k) clearance for RETeval Visual Electrodiagnostic Device by Lkc Technologies, Inc.. It is a Class 2 Neurology device (product code GWE) cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K142567 · Lkc Technologies, Inc. · Neurology device
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May 2015
Decision
249d
Days
Class 2
Risk

K142567 is an FDA 510(k) clearance for the RETeval Visual Electrodiagnostic Device. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Lkc Technologies, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on May 19, 2015 after a review of 249 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lkc Technologies, Inc. devices

Submission Details

510(k) Number K142567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2014
Decision Date May 19, 2015
Days to Decision 249 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 148d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWE Stimulator, Photic, Evoked Response

All 16
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K142567.
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